Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010929

Trial Description

start of 1:1-Block title

Title

Prospective trial for evaluation of potential heart dose reduction using deep inspiration breath-hold in radiotherapy of left-sided breast cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Objective of the study is to evaluate how the heart dose during radiotherapy with surface surveillance of left-sided breast cancer can be significantly reduced by a gated radiotherapy in deep inspration and in a second step to check how a radiotherapy in deep inspiration breath-hold can be implemented and monitored in clinical routine.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Objective of the study is to evaluate how the heart dose during radiotherapy of left-sided breast cancer can be significantly reduced by a gated radiotherapy (gated deep inspiration breath-hold with audio-visual feedback) in deep inspration and in a second step to check how a radiotherapy in deep inspiration breath-hold can be implemented and monitored in clinical routine. For gated treatment a surface-scanner and individual audio-visual feedback with loudspeaker announcements and video glasses were used.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010929
  •   2016/08/05
  •   [---]*
  •   no
  •   Approved
  •   496-12, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C50.9 -  Malignant neoplasm: Breast, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Irradiation and Planning in deep inspiration breath-hold for left sided breast cancer patients using the sentinelTM/catalystTM surface System and automatic interconnection for beam-on/-off Signal via ELEKTA Response II TM Interface. For Treatment planning the oncentra 4.3 Software was used.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

significant heart dose reduction in planning and Treatment checked by heart inside Treatment field and further Parameters like heart mean and max dose as well as max LAD (left anterior descending artery) dose.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

lung dose assessment (mean lung dose, left lung V20Gy), target dose coverage (V95%), clinical feasability

Follow-Up using Lent-Soma Criteria

Follow-Up for cardiac toxicity (10-20 years) no endpoint of this study

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/11/01
  •   13
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

left-sided breast cancer
indication for adjuvant whole breast irradiation

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

informed consent not possible
breath-hold of 20 seconds not possible

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • C-RAD AB
    • 75320  Uppsala
    • Sweden
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinikum Großhadern Klinik für Strahlentherapie und Radioonkologie
    • Mr.  Prof. Dr. med.  CLaus  Belka 
    • Marchioninistraße 15
    • 81377  München
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinikum Großhadern Klinik für Strahlentherapie und Radioonkologie
    • Mr.  Prof. Dr. med.  CLaus  Belka 
    • Marchioninistraße 15
    • 81377  München
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • ELEKTA AB
    • 10393  Stockholm
    • Sweden
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • C-RAD AB
    • 75320  Uppsala
    • Sweden
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/12/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.